Showing posts sorted by date for query Pimavanserin. Sort by relevance Show all posts
Showing posts sorted by date for query Pimavanserin. Sort by relevance Show all posts

Wednesday, August 31, 2016

Nuplazid (pimavanserin) tablets approved to treat hallucinations and delusions



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In continuation of my update on Nuplazid (pimavanserin)


The U.S. Food and Drug Administration today approved Nuplazid (pimavanserin) tablets, the first drug approved to treat hallucinations and delusions associated with psychosis experienced by some people with Parkinson's disease.

Hallucinations or delusions can occur in as many as 50 percent of patients with Parkinson's disease at some time during the course of their illness. People who experience them see or hear things that are not there (hallucinations) and/or have false beliefs (delusions). The hallucinations and delusions experienced with Parkinson's disease are serious symptoms, and can lead to thinking and emotions that are so impaired that the people experiencing them may not relate to loved ones well or take appropriate care of themselves.

"Hallucinations and delusions can be profoundly disturbing and disabling," said Mitchell Mathis, M.D., director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research. "Nuplazid represents an important treatment for people with Parkinson's disease who experience these symptoms."

An estimated 50,000 Americans are diagnosed with Parkinson's disease each year, according to the National Institutes of Health, and about one million Americans have the condition. The neurological disorder typically occurs in people over age 60, when cells in the brain that produce a chemical called dopamine become impaired or die. Dopamine helps transmit signals between the areas of the brain that produce smooth, purposeful movement -- like eating, writing and shaving. Early symptoms of the disease are subtle and occur gradually. In some people Parkinson's disease progresses more quickly than in others. As the disease progresses, the shaking, or tremor, which affects the majority of people with Parkinson's disease, may begin to interfere with daily activities. Other symptoms may include depression and other emotional changes; hallucinations and delusions; difficulty in swallowing, chewing, and speaking; urinary problems or constipation; skin problems; and sleep disruptions.

The effectiveness of Nuplazid was shown in a six-week clinical trial of 199 participants. Nuplazid was shown to be superior to placebo in decreasing the frequency and/or severity of hallucinations and delusions without worsening the primary motor symptoms of Parkinson's disease.

As with other atypical antipsychotic drugs, Nuplazid has a Boxed Warning alerting health care professionals about an increased risk of death associated with the use of these drugs to treat older people with dementia-related psychosis. No drug in this class is approved to treat patients with dementia-related psychosis.

In clinical trials, the most common side effects reported by participants taking Nuplazid were: swelling, usually of the ankles, legs, and feet due to the accumulation of excessive fluid in the tissue (peripheral edema); nausea; and abnormal state of mind (confused state).

Nuplazid was granted breakthrough therapy designation for the treatment of hallucinations and delusions associated with Parkinson's disease. Breakthrough therapy designation is a program designed to expedite the development and review of drugs that are intended to treat a serious condition and where preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint. The drug was also granted a priority review. The FDA's priority review program provides for an expedited review of drugs that offer a significant improvement in the safety or effectiveness for the treatment, prevention, or diagnosis of a serious condition.

Thursday, December 26, 2013

Novel drug combats psychosis in Parkinson’s disease

The non-dopaminergic drug pimavanserin reduces psychotic symptoms in patients with Parkinson’s disease (PD) without worsening motor function, shows a randomized trial.

In a press statement, lead researcher Clive Ballard (King’s College London, UK) stressed that “the clinical benefits of pimavanserin were seen by patients, those caring for them, and independent blinded raters alike.”

Along with observed improvements in sleep, this suggests that tackling psychosis had “a broader effect on wellbeing of patients,” write Ballard and colleagues in The Lancet.

A total of 199 patients participated in the study, 185 of whom were included in the final analysis; all had a combined score of at least 6 on the neuropsychiatric inventory items delusions and hallucinations, or an individual score of at least 4. 

The researchers tried to provoke a placebo effect ahead of the start of drug treatment by first providing all patients with 2 weeks of psychosocial therapy. Nevertheless, patients assigned to the placebo group still had a 14% reduction in psychotic symptoms on the PD-adapted Scale for Assessment of Positive Symptoms (SAPS) over the 6-week study period.

However, patients taking pimavanserin – a selective serotonin 5-HT2A inverse agonist – had a significantly larger 37% improvement.

In an accompanying commentary, Susan Fox (Toronto Western Hospital, Ontario, Canada) writes: “Overall, the study opens up a new therapeutic avenue in treatment of Parkinson's disease psychosis.”


Thursday, December 5, 2013

New Drug Shows Early Promise in Treating Parkinson's Psychosis

We know that, Pimavanserin (ACP-103) is a drug developed by Acadia Pharmaceuticals which acts as an inverse agonist on the serotonin receptorsubtype 5-HT2A, with 40x selectivity over 5-HT2C, and no significant affinity or activity at 5-HT2B or dopamine receptors. As of September 3 2009, pimavanserin has not met expectations for Phase III clinical trials for the treatment of Parkinson's disease psychosis, and is in Phase II trials for adjunctive treatment of schizophrenia alongside an antipsychotic medication. It is expected to improve the effectiveness and side effect profile of antipsychotics...

Now  a study published in the Nov. 1 online issue of The Lancet and funded by Acadia Pharmaceuticals, the makers of pimavanserin.
"There are no first-line approved treatments for psychosis in people with Parkinson's disease," said lead researcher Dr. Clive Ballard, a professor of age-related diseases at King's College, London.
"Existing antipsychotics are either ineffective or not tolerated. Pimavanserin is not yet licensed, but could potentially offer a change in the treatment of these distressing and impactful symptoms," he said.
An expert not involved with the study talked about the need for a medication alternative.
"The Parkinson's disease community has been waiting for a potentially new approach for the treatment of psychosis and hallucinations," said Dr. Michael Okun, national medical director of the National Parkinson Foundation.